Device and method for treating vascular and other diseases of extremities



p 9, 1969 v. A. KRAVCHENKO 3.465,?48

DEVICE AND METHOD FOR TREATING VASCULAR AND OTHER DISEASES OF EXTREMITIES Filed Oct. 25, 1966 United States Patent DEVICE AND METHOD FOR TREATING VASCULAR AND OTHER DISEASES OF EXTREMITIES Vasily Afanasievich Kravchenko, Ulitsa Bozhenko 14, korp. 4, kv. 25, Moscow, U.S.S.R. Filed Oct. 25, 1966, Ser. No. 589,327 Int. Cl. A61]: 1/00 U.S. Cl. 128-24 5 Claims ABSTRACT OF THE DISCLOSURE This invention relates to a method whereby vascular diseases of the extremities such as obliterating endarteritis (Endarteritis obliterans) as well as other diseases affecting the human extremities, e.g. rheumatism, are treated, and likewise to a device for carrying the method into effect.

More specifically, the invention is concerned with both the method and the device for treating the aforementioned afllictions of the human extremities according to which the latter are put into a pressure chamber provided in the device and treated by an active (arterial) hyperemia and the creation of a differential barometric pressure between the extremity and the pressure chamber in case of decompression, and between the pressure chamber and the extremity in case of compression.

Similar methods and devices for treatment of the abovesaid diseases are now in common use. In particular, use is made nowadays of a curing method with a passive (venous) hyperemia and a differential barometric pressure built up in decompression phases (vacuum) up to 685 mm. Hg and with a compression (excessive pressure) up to 860 mm. Hg in association with a thermotherapy of the extremity involved.

When applying the abovementioned curing method, in case of a decompression up to 685 mm. Hg, the extremity under treatment is pulled into the pressure chamber with a tractive force up to 40 kg., whereupon it is constricted by applying a pressurizing collar which results in the venous and arterial circulatory disturbance; this, in turn, reduces abruptly gas exchange in the cells of hypoxic tissues. When exposed to a compression phase of up to 860 mm. Hg, the extremity turns pale, the blood flow ceases and gas exchange in the cells stops for a whole period of compression. Apart from this, as the compression phase is being built up, the ever increasing pressure tends to push the extremity away from the pressure chamber. The abovedescribed method and device based upon the principle of passive hyperemia, however, proved to be but of low effect even when applied for treating the incipient stages of obliterating endarteritis and atherosclerosis of of extremities.

Another method of treating affected extremities is now made use of, viz by applying massotherapy by means of alternatively changing decompression phases of up to 685 mm. Hg, the period of the lowest pressure in each phase lasting 15 to 25 sec., and a compression phase of up to 900 mm. Hg of same duration. The devices Vasotrein (the light iron-made extremities) are employed for 3,465,748 Patented Sept. 9, 1969 carrying the above method into effect, these devices be ing designed upon the principle of the apparatus of passive hyperemia which have been described in the magazine Medizinal-Markt, 1958, No. 9, pp. 321-322 published in German Federative Republic as well as in a prospectus issued by the firm Franz Itting, Ludwigsstadt, Bavaria, GFR.

The abovementioned device is essentially a pressure chamber made of a transparent material and on one of its sides provided with a locking chamber and an aircushion for pressurizing the extremity contained in the pressure chamber; provision is made inside the latter of a horizontal support for positioning the arm or leg being treated.

Both the method and the device mentioned afore find application in treating extremities affected with vascular diseases (both arterial and venous) of various origin and etiology which do not respond to any other therapeutic methods of treatment, the employment of the method in each particular case being the function of the kind, form and the degree of gravity of the disease being cured.

The above-said method may be considered to be resorted to for treating the following diseases (as stated in the above-mentioned prospectus of the firm Franz Itting): atherosclerosis, intermittent claudication, endoangiitis, Buergers disease, Raynauds disease, Sudecks disease, the initial stage of gangrene, frost-bite, joint deformity (deformatio articularis), posttraumatic lesions of vessels, circulatory disturbance due to thrombosis, or thrombophlebitis, varicose ulcer of the leg (ulcus cruris), varicosis, postpoliomyelitic paralysis.

Practically, the above-mentioned method of treatment, due to too small difference between the barometric pressures of the extremity and that within the pressure chamber and low duration of decompression and compression phases (4 to 6 minutes), enables only the pumping of blood over from place to place, i.e. sucking it from the organism into the veins of the extremity in case of decompression phase, and expelling the blood back into the organism in case of compression phase, thereby affording rubbing massage to the tissues and blood vessels of the affected extremity. In this case, however, no increase of gas exchange within the cells of hypoxic tissues takes place during decompression phase whereas in the course of compression phase it is suppressed sharply during 7-10 minutes that the curing procedure lasts.

Besides, the aforesaid method is known to provoke passive hyperemia in the affected extremity, this being due to the fact that while decompression phases are being built up, only the arterial blood inflow towards the veins takes place, and the venous blood outflow during decompression is passive; thus, in order to intensify the outflow of blood from the veins, compression phases are created in the course of the curing procedure. As a result, the outflow of venous blood increases whereas the inflow of arterial blood during compression phases becomes passive.

All the aforesaid results in that during the alternation of pressure phases (7 to 10 min.) passive hyperemia (venous statis) occurs in the arteries of the extremity under compression phase while under decompression phase the same phenomenon takes place in the veins. Apart from this, only an inconsiderable portion of the arterial blood in the extremity passes through anastomoses into the veins during compression phases; that portion of the blood complete with the blood arrived in the veins during decompression phase is expelled into the human organism with various toxic acids suboxided. Inasmuch as the veins are provided with non-return valves which prevent the unnatural reverse flow of blood, and the arteries are devoid of such valves, a major portion of the blood is expressed back into the arterial system of the human organism.

3 or 4 recurrent compression phases that occur when applying the above method, cause the lymph together with intercellular juice containing nutritives for cells, to be squeezed out from the affected extremity. Thus, the abovesaid juice fails to penetrate through the arterial walls into the intercellular space during a short lapse of decompression phases, especially in case of persistent spastic phenomena in the vessels of the extremity or any pathological alterationsin the vascular walls; this, in turn, makes it impossible for the cells which are in hypoxic surrounding, to be fed with nutritives from the intercellular juice in the course of the treating procedure.

All attempts that have been made to treat vascular and other diseases of the human extremities by applying the aforementioned methods, however, proved to be ineffective in case of moderate and severe forms of diseases as these methods and devices to some extent disturb blood circulation and drastically reduce gase exchange in the cells of hypoxic tissues of the affected extremity, this being due to passive hyperemia built up therein as well as to too small difference in the barometric pressure of the extremity and that within the pressure chamber.

The aforementioned disadvantages of the known methods of treatment must be assigned to the fact that, under the condition of passive hyperemia and a small difference in the barometric pressure of the extremity and Within the pressure chamber, the molecules of oxygen are not capable of penetrating from the blood through the spastic or pathologically changed vascular walls as well as through hypoxic tissues into the cells and their metachondria wherein gas exchange and oxidative phosphorylation take place; to increase both the abovesaid processes, a higher differential barometric pressure between the extremity and the pressure chamber as well as active hyperemia should be created which enlarge correspondingly the difference in partial pressures of oxygen be tween the blood, the cells of tissues and their metachondria; as a result, the penetration of oxygen through the vascular walls into the cells is substantially enhanced. It is only due to the abovesaid fact that gas exchange in the cells of tissues as well as oxidative phosphorylation in their metachondria can be intensified.

All theoretical aspects set forth above will help to make the character of the invention more apparent.

It is an object of this invention to provide a means which ensures a more effective and expedient treatment of vascular and other diseases affecting the human extremities, and first and foremost, the treatment of vascular walls to restore their permeability and flexibility so as to intensify gas exchange in the cells of hypoxic tissues.

It is another object of this invention to augment an artificially developed difference in the barometric pressure of the extremity and within the pressure chamber, and thereby to increase the difference in partial pressures of oxygen between the blood and the cells so as to intensify gas exchange in the cells of hypoxic tissues of the affected extremity.

It is also an object of this invention to augment the permeating (perforating) ability of the molecules of oxygen so as to overcome the imperviousness of the vascular walls in the affected extremity due to spastic or pathological phenomena therein thus rendering the possibility for said molecules to pass from the blood towards the cells and the metachondria thereof.

It is one more object of this invention to provide a means for obtaining active (arterial) hyperemia during the curing procedure when the affected extremity is enclosed in a pressure chamber.

It is an additional object of this invention to provide an effective method of treating vascular and other diseases of the human extremities in their moderate and extreme stages as well as the initial stages of same diseases for shorter periods of time and with a prolonged remoteness.

According to the invention, an active (arterial) hyperemia is created in the affected extremity contained in a pressure chamber, the negative barometric pressure inside said chamber being within the range of 680 to 400 mm. Hg, thus giving no possibility for the active hyperemia to be converted into the passive one.

To bring about an intensified gas exchange in the cells of hypoxic tissues of the affected extremity, it is advisable to saturate the blood with oxygen by way of inhalation during the curing procedure.

It is for the purpose of effecting active hyperemia in the extremity during the procedure that provision is made in the device of the invention for a special stop capable of retaining the extremity fixed in position on a support contained within the pressure chamber, both the support and the stop being so made as to be free to travel in longitudinal direction with respect to the pressure chamber, and can be set in any predetermined position as to the chamber length by means of a locking device.

In the embodiment of the invention described herein the abovesaid device for locking i position the support with the stop retaining the extremity, is essentially a rack (a toothed rack in the case of preferred embodiment) which is made fast on the wall of the pressure chamber and a spring-loaded dog which is coupled to said support and is capable of engaging said toothed rack when pressing upon the support with the heel of the leg or with the first of the arm being treated.

To retain the extremity within the pressure chamber when compression phase is developed therein, it is expedient that flexible tying means be provided on the outside of said chamber, such as straps with which the patient is retained in place during the procedure.

The abovedescribed means enable the development in the affected extremity during a procedure lasting 1525 minutes, of an active hyperemia and a high differential barometric pressure between the extremity and the pressure chamber and, thereby, that of partial pressures of oxygen in the blood and cells of tissues which differential pressure makes the molecules of oxygen more elastic and heightens their perforating ability which, in turn, causes the molecules to distend and expand (harmlessly to the vascularity) the spastic or pathologically altered vascular walls and clear spaces therein thus contributing to the accelerated penetration of the oxygen molecules from the blood through the distended vascular walls and clear spaces therein as well as through the hypoxic tissues into the cells and further on to the metachondria thereof. While passing through the abovementioned tissues and cells oxygen oxidates some suboxide substances, such as histoline, lipides, lactic, citric, pyroracemic and some other acids, starting from the vascular walls and up to the cells, at the same time exerting curative effect upon the walls of vessels, eliminating hypoxia of the tissues, intensifying both arterial and venous blood flow with every procedure, as well as restoring the flexibility of vessels and the normal perviousness of their walls, gas exchange and oxidative phosphorylation in the metachondria of the cells.

As the result of the measures taken, painful sensations disappear even after the initial two procedures, as in the case of the grave stage of the obliterating endarteritis complicated with dry gangrene in its incipient stage.

Further objects, peculiarities and advantages of the present invention will become apparent from the following description and the accompanying drawing which illustrates the device with the extremity contained within the pressure chamber thereof, as the specific and preferred embodiment of the invention.

A device which is employed for practicing the proposed method of treatment, is essentially a cylindrical pressure chamber 1 made of a transparent material and provided at both end faces with air-tight flanges 2 and 3. The flange 2 has an opening for the extremity to pass into the pressure chamber 1 and a hollow ring '4 with a hollow flexible collar 5 for pressurizing the extremity contained within the pressure chamber 1.

The ring which is inserted into the opening in the flange 2 is so selected as to suit the diameter of the extremity being treated. Communicating with the hollow space of the aforesaid collar 5 is a flexible bulb 6 capable of inflating said space with air whereas provision is made on the flange 2 for a valve 7 for regulating the pressure inside the hollow space of the collar '5.

Located within the pressure chamber 1 is a horizontal support 8 mounted on guides 10 along which said support is free to move in longitudinal direction with respect to said chamber, a stop 9 being provided on said hori- Zontal support to hold in place the extremity being treated.

The support 8 is connected to a spring-loaded dog 11 which is capable of being engaged with a toothed rack 12 when pressing upon said support, said toothed rack being made fast on the wall of said pressure chamber beneath the support 8.

The spring-loaded dog 11 and the toothed rack 12 in conjunction with each other form a locking device with which the support 8 can be locked in any preset position within the pressure chamber with respect to the length thereof.

The pressure chamber 1 is mounted on a carriage 13 which at its front is provided with a device 14 for lifting the chamber 1 which is needed for convenient disposition of the extremity under treatment.

An electrically driven pump 15 capable of building up a pressure inside the pressure chamber 1 can be mounted on a control board.

Straps 16 are provided on the outside of the pressure chamber 1, said straps being fastened to the patients waist while an excessive pressure is being built up inside the pressure chamber, said straps retaining the patient in place during the procedure when the ever increasing pressure within the chamber tends to push the patients extremity away therefrom.

Provision can likewise be made for an additional thermal effect on the tissues of the affected extremity by utilizing a heating element 17 mounted in the flange 3 of the pressure chamber 1.

The process of treatment by applying the method and device of the invention is as follows.

First of all, the patient should be subjected to a comprehensive examination by way of general analyses as well as to special investigations such as thermometry of the skin in the affected extremity, arterial oscillography, capillaroscopy, plethysmography as well as testing for oxygen content in the arterial and venous blood. According to indications thus obtained the kind and stage of the disease as well as its prognosis can be judged.

Further, the ring 4 complete with collar *5 is to be so selected as to suit the size of the affected extremity, e.g. the leg, whereupon the latter is placed into the pressure chamber 1 so as to slightly touch the surface of the collar 5 of the ring 4. Then by pressing upon the heel rest of the support 8, the dog 11 is made to engage the toothed rack 12 whereby the extremity is fixed in position relative to the pressure chamber 1; this done, one should inflate the collar 5 of the ring 4 with air by manipulating the bulb 6 until the slight touch of the collar 5 and the surface of the extremity is attained. When the barometric pressure within the chamber drops, the collar 5 expands and compresses the extremity; in such cases one should open the valve 7 and bleed the air away from the collar until the atmospheric air starts inflowing slightly into the pressure chamber through the contact area of the collar and the extremity which is indicated by a pressure gauge 18; after this the collar 5 is again inflated by using the bulb 6 until the former touches the surface of the extremity, taking care not to constrict the blood vessels excessively which can be easily checked by pressing upon the collar with the finger.

In case of compression, one should proceed likewise. The constructional peculiarities of both the air-inflatable collar 5 and the ring 4 enable quick and reliable pressurization of the pressure chamber as well as the extremity thereinside painlessly for the patient.

Due to the measures taken, the creation of active hyperemia in the extremity is obtained.

Having ascertained that no constriction of tissues in the area of the pressurizing collar 5 is observed and the extremity is held in position within the pressure chamber reliably, one may proceed to treat the affected extremity by exposing it to a decompression phase within the limits of 680 to 400 mm. Hg lasting from 10 to 25 minutes and applied once or twice per procedure depending upon the form and stage of the disease concerned.

In those cases where the vains are found to be painful and weak and the blood vessels to be in atonic condition, the course of treatment requires the use of high decompression from 680 to 550 mm. Hg, and the extremity is required to be bound up with an elastic bandage.

Thereupon the second phase of the procedure is performed wherein as excessive pressure up to 900 or 1000 mm. Hg is built up lasting from 1 to 3 minutes.

The procedure is terminated in the third phase with a decompression which lasts 5 to '7 minutes. In the latter case only principal attitude towards the curing method is herein described. The main curative factor in the method involved consists in a decompression applied for 10 to 20 minutes since only this can intensify gas exchange in the cells and exert a curative effect upon the vessels whereas compression, on the contrary, suppresses gas exchange and therefore, affords only massotherapeutic effect and eliminates oedema of the extremity.

As a rule, the initial two procedures are trial periods, in the course of which the necessary parameters of the curing procedure are selected. On this account, during the initial procedures the duration of decompression phases is administered to be the minimum, that is from 680 to 640 mm. Hg.

If during the procedure and thereafter, the patient feels satisfactory and his cardiac activity is found to be satisfactory too, in the subsequent procedures the degree of decompression is gradually increased by 5 or 10 mm. Hg until reaching the value which depends upon the kind and stage of the disease as well as upon the predetermined course of treatment.

In all cases the treatment procedure is preferably conducted with the patient inhaling oxygen.

Thus in the case of initial obliterating endarteritis (1st stage of the spastic form), the first coarse of treatment consists of 12 or 15 procedures, the maximum dosing of the negative pressure being within 680 to 635 mm. Hg.

When treating spastic obliterating endarteritis of the third degree and atherosclerosis of the second degree with concomitant complicated dry gangrene of fingers or toes without inflammation and oedema of the foot, the range of decompression in the initial two (trial) procedures is prescribed to be from 680 to 630 mm. Hg, and subsequently, from 645 to 580 mm. Hg, the duration of treatment being from 30 to 35 procedures.

As a rule, to preclude the onset of phlebectasis in cases of decompression (vacuum) higher than 630 mm. Hg, the extremity is to be bound up slightly with an elastic bandage till touching the pressurizing ring.

It' should be pointed'out that treating of both extremities immediately one after the other is in no case permissible, a lapse of time (15 to 20 min.) between the procedures being a necessary requirement otherwise, a collapse may occur. It is for this reason that the initial two One hundred patients have been treated in 1965, the results of treatment being tabulated below.

Results of treatment Degree of disease No. of

Patients No effect Clinical diagnosis I II III treated Age Male Female Good Satisfactory whatever Endarteritis obliterans 10 10 7 3 18 18 16-45 26 4 8 7 3 12 12 3 5 4 Atheroselerotic occlusions revealed in:

(1) Bit'urcations ol the aorta and iliac arteries 2 7 3 12 30G5 10 2 4 4 4 (2) Femoral and popliteal arteries 12 28 8 48 25--70 44 4 16 24 g Total 24 53 23 100 90 10 38 43 1 trial procedures are administered to investigate the degree of dilatation of arterioles.

The method of treatment described hereinabove is likewise applicable for curing the initial stage of hypertension in atherosclerosis of the human extremities.

In such cases the same curing technique is practicable complete with oxygen inhalation in the course of the procedure, the degree of decompression being prescribed depending upon the subjective condition of the patient and that of his cardio-vascular system.

The present invention may find utility in treating rheumatism of extremities, polyarthritis infectiosa deformans, trophic ulcers and weeping eczema of the microbis origin.

All the diseases mentioned above are treated by applying decompression only, except polyarthritis infectiosa deformans which, upon carrying out 10 to decompression procedures and in case of normal E.S.R. is conducted further on by following one of the above described curing technique, the duration of the decompression procedure being from 7 to 15 minutes.

The degree of decompression prescribed in treating polyarthritis infectiosa deformans ranges within 680 to 600 mm. Hg (with the leg bound up in case of weak veins), the number of procedures totalling up to 25 or 30.

In case of rheumatism the degree of decompression ranges within 680 and 620 mm. Hg, the binding up of the extremity with an elastic bandage being likewise necessary.

It is essential to note that the device of the present invention is likewise effective in treating torpid wounds and trophic ulcers where necessity arises of binding up the extremity with an aseptic bandage and using cotton wool. Considerable improvement and disappearing of painful sensations occur even after the initial 2-3 procedures while the complete recuperation comes after 15 to procedures, the results of treatment being most durable and persistent.

A patient suffering from endarteritis obliterans complicated with dry gangrene passed a course of treatment consisting of 27 procedures in 1946, another such patient did so in 1954, none of the patients on completion of the treatment course having ever resorted to medical advice on vascular diseases subsequently. The medical examination of these patients conducted in 1964 revealed that pulsation in the extremities was normal distinctly palpable, both of the former patients moved easily and did not complain of any pain in the extremities though one of them was already 76 years old.

There is a number of some other case histories to cite.

As can be seen from the above table, over percent of results obtained are positive.

At present the method and device proposed have passed clinical study and are found to be effective in treating the aforementioned diseases.

What is claimed is:

1. A method of treating vascular and other diseases of the extremities, comprising placing the affected extremity in a pressure chamber, producing active hyperemia in said extremity while producing a negative pressure in the pressure chamber of 400 to 680 mm. Hg for increasing the difference in the partial pressures of oxygen in the blood and in the cells of tissues of said extremity to intensify gas exchange in the cells of hypoxic tissues, While preventing the abovesaid active hypermia from converting into a passive one during the period in which the extremity is in said pressure chamber.

2. A method as claimed in claim 1 whereby intensification of gas exchange in the cells is attained through the saturation of the blood with oxygen by way of inhalation.

3. A method as claimed in claim 2 wherein said negative pressure is maintained for a period of 10 to 25 minutes, whereafter the chamber is pressurized at a value of 900 to 1000 mm. Hg for 1 to 3 minutes and then depressurized for 5 to 7 minutes.

4. A device for treating vascular and other diseases of extremities comprising: a pressure chamber adapted for receiving the affected extremity; a flexible collar on one side of said pressure chamber for pressurizing an extremity placed in said chamber; a support in the chamber for the extremity, means mounting said support within said pressure chamber for free longitudinal movement therein; stop means on said support for the extremity to bear against, and a locking device within said pressure chamber for holding said support in a preset longitudinal location within said pressure chamber, said locking device comprising a toothed rack in said pressure chamber, and a spring-loaded dog coupled to said support and engageable with said rack while pressing upon said support.

5. A device as claimed in claim 4 wherein said stop means is connected to said spring-loaded dog and is locked in position by the engagement of said dog with said rack.

References Cited UNITED STATES PATENTS Re. 2,276 6/1866 Jones 128-298 2,055,128 9/1936 Herrmann 12838 2,098,272 11/1937 Benson 12838 L. W. TRAPP, Primary Examiner 

